Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213977
Company: TEVA PHARMS USA
Company: TEVA PHARMS USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ONSURA | ETHINYL ESTRADIOL; NORELGESTROMIN | 0.035MG/24HR;0.15MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
08/25/2021 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/29/2022 | SUPPL-1 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
ONSURA
FILM, EXTENDED RELEASE;TRANSDERMAL; 0.035MG/24HR;0.15MG/24HR
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ETHINYL ESTRADIOL AND NORELGESTROMIN | ETHINYL ESTRADIOL; NORELGESTROMIN | 0.035MG/24HR;0.15MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB | 213950 | AMNEAL |
ETHINYL ESTRADIOL AND NORELGESTROMIN | ETHINYL ESTRADIOL; NORELGESTROMIN | 0.035MG/24HR;0.15MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB | 214594 | ZYDUS NOVELTECH INC |
ONSURA | ETHINYL ESTRADIOL; NORELGESTROMIN | 0.035MG/24HR;0.15MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB | 213977 | TEVA PHARMS USA |
XULANE | ETHINYL ESTRADIOL; NORELGESTROMIN | 0.035MG/24HR;0.15MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB | 200910 | MYLAN TECHNOLOGIES |